The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric

Phase 2

• Conditions: Gastric Cancer
• Interventions: Procedure: Uncut Roux-en-Y Reconstruction; Procedure: Billroth II Reconstruction

• Registration Number: NCT02694081
• Lead Sponsor: Jilin University

Brief Summary

The Advantages and Disadvantages Between Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction After Laparoscopy-assisted Distal Gastrectomy for Gastric.

Detailed Description

To search which is the better reconstructions by comparing and analyzing the advantages and disadvantages between Uncut Roux-en-Y and Billroth II reconstructions after laparoscopy-assisted distal gastrectomy for gastric cancer.

Method: It's a prospective study including all patients underwent laparoscopy-assisted distal gastrectomy (LADG) in the First Hospital of Jilin University, from February 2016 to February 2017. All surgical procedures will be performed by the single surgery team, which is leaded by professor Wang Quan. The reconstruction method will be selected randomly from Uncut Roux-en-Y and Billroth II anastomosis by drawing lots preoperatively without distinct indications. Clinical data, operation data and perioperative complications and related physiological indexes of differences.

Study Timeline

• Study First Submitted: 2016-01-29
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-29
• Status Verified: 2016-07
• Last Update Submitted: 2016-12-29
• Last Update Posted: 2017-01-02
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Clinical diagnosis of distal gastric cancer
• underwent laparoscopy-assisted distal gastrectomy

Exclusion Criteria

• have simultaneously other cancer
• have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
• have upper gastrointestinal surgery
• can't bear the gastric tube
• the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uncut Roux-en-Y Reconstruction	Uncut Roux-en-Y Reconstruction	Uncut Roux-en-Y Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer.
Billroth II Reconstruction	Billroth II Reconstruction	Billroth II Reconstruction will be used after laparoscopy-assisted distal gastrectomy for early gastric cancer.

Primary Outcome Measures

Name	Time	Method
change of potential of hydrogen ( pH) in remnant stomach	1-6 days after surgery	In the morning of 1-6 days after operation , monitor the number of gastric juice's potential of hydrogen ( pH) value through gastric tube and write down the data. So if the data is greater than 7,the complication of bile reflux happened
The time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction	within 2 hours after surgery	The time of reconstruction operation will be recorded in the operating note by nurses in minutes.
the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction	within 2 hours after surgery	During the operation the amount of blood loss will be recorded in the operating note by nurses in milliliters.

Secondary Outcome Measures

Name	Time	Method
the number of patients with the complication of Reflux esophagitis	6 month after surgery	During the upper gastrointestinal radiography,if there is meglumine diatrizoate refluxing to esophagus,it will be observed and written down in number.
the number of patients with the complication of Residual food	6 month after surgery	During the upper gastrointestinal radiography，if there is residual food,the meglumine diatrizoate will be separate and then write down the number.

Trial Locations

Locations (1)

the first hospital of Jilin University; 🇨🇳 Changchun, Jilin, China